Liquid pharmaceuticals are commonly delivered to patients through injection or infusion. Such delivery is generally made in one of two ways. The first is an immediate delivery from a health care provider in the form of a simple injection performed with a syringe and a needle directly disposed to the tissue of the patient. The second is gradual delivery, wherein a syringe or other reservoir is connected to specific medical tubing for delivery over time.
Frequently, syringe pumping systems such as Sealfon U.S. Pat. No. 5,741,227 teaching a Method of Sterile Preparation of IV Pump Syringe are used. As noted, Sealfon teaches a number of advantages for maintaining the sterility of the tubing set 14, coupling the tubing set 14 to the syringe 12, and disposing the coupled syringe 12 within a syringe pump 10.
More specifically, Sealfon teaches a disc 48 that is added to the tubing set 14 at the connector end interposed between the tubing set per se inlet 34 and a tubing engaging means 50. This disc 48 has been shown to provide and perform many advantages. For example, this disc 48 serves to elevate the tubing end from surfaces, thereby promoting the sterile condition of the tubing end, if and/or when it is set down when unconnected to a syringe.
In addition, the disc 48 provides a convenient brace for an operator's fingers during the coupling of the tubing set to a syringe—the disc 48 further preventing slippage of the fingers over the inlet 34 that again promotes sterility of the inlet 34. And further still, the disc provides a brace for the syringe pump 10, ensuring that when the coupled syringe 12 and tubing set 14 are disposed within the syringe pump 10, the disc 48 provides a brace against which the force of the syringe pump 10 serves to temporarily lock the coupled syringe 12 and tubing set 14 in place.
By using calibrated tubing and needles together with a constant pressure pump, such as the Sealfon '227 syringe pump, it is possible to virtually guarantee safe delivery of a liquid to tissue. When saturation of the tissue occurs the resistance to the flow increases and the system immediately self adjusts by lowering the flow. Indeed when the tissues have received enough liquid such that the pressure within the tissues equals the pressure from the pump, the flow of the administered liquid will cease. In terms of patient care, this is highly advantageous because it vastly reduces the chance for accidental over medication.
As with constant pressure systems, with constant flow systems calibrated tubing and needles are once again commonly used. However, with the constant flow system, as pressure increases at the receiving site the system will increase pressure to maintain the desired flow and over medication can result. Moreover, the focus on maintaining constant pressure can result in detrimental treatment for the patient.
However, a factor in both constant flow and constant pressure is use of the correct tubing. The availability of third party tubing having a disc as taught by Sealfon '227 has introduced the possibility that despite best intentions, unwarranted tubing may be used that does not conform to the desired calibrations. As such unintended dosage may result and adversely affect the patient.
In addition, different tubing lines intended for different liquids providing different pharmaceuticals may be crossed leading to wrong substances being provided to the wrong tissues. As the use of the disc as taught by '227 is highly useful in protecting the inlet and as a brace during tubing set connection, the disc itself does not aid in avoiding misconnections.
Moreover, as the use of the disc is not in and of itself protected, although competition within the marketplace is generally good, the availability of different tubing options utilizing a disc has introduced potential problems that may adversely affect patient health and care.
Hence there is a need for a tubing set alone, and tubing set with a syringe pump which overcome one or more of the above identified challenges.